MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALCIUM GEN.2; CALCIUM TEST SYSTEM

Model Number	08057427190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for calcium gen.2 (ca2), on a cobas c 503 analytical unit.The initial result was 2.4 mg/dl.The technician questioned this result.The sample was repeated on a different c503 analyzer with a result of 8.86 mg/dl.This result was believed to be correct.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).
Additional Manufacturer Narrative
Calibration was acceptable.The alarm trace data showed abnormal aspiration alarms.These are indicators of possible poor sample quality.The field service engineer (fse) found the instrument was operating properly.Instrument performance testing and precision results were acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CALCIUM GEN.2
• Common Device Name: CALCIUM TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24637006
• Report Number: 1823260-2026-00991
• Device Sequence Number: 21281350
• Product Code: CHW
• UDI-Device Identifier: 07613336121092
• UDI-Public: 07613336121092
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 08057427190
• Device Catalogue Number: 08057427190
• Device Lot Number: 92024001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Male